Introducing REACH: EU’s New Chemical Policy

Introducing REACH: EU’s New Chemical Policy

by Mary Majors, Air Products and Dawn Speranza, Intel

On June 1, 2007 the European Union (EU) will enact a new chemical policy known as “REACH”, an acronym for the “Registration, Evaluation and Authorisation of Chemicals”. REACH applies to all existing substances, including those listed on the European Inventory of Existing Commercial Chemical Substances (EINECS) and any new substances manufactured for the first time in the future. Substances on the European List of Notified Chemical Substances (ELINCS) are considered already registered.

REACH is an extremely ambitious chemical strategy—replacing 40 existing EU laws and impacting multiple industries. The goals of the new regulation include:

Improved protection of human health and the environment

Enhancement of competitiveness and innovation in the EU

Placement of responsibility for risk management on the legal entities that manufacture, import, place on the market, or use the substances

Due to the increased hazard information and improved exposure control for dangerous substances, the EU expects significant improvements in public health and pollution prevention. The new European Chemicals Agency (ECHA) will administer REACH and coordinate the required activities.

REACH is a substance registration—not a product registration. REACH will require manufacturers and importers to register substances placed on the market in the EU above volumes of 1 metric ton (MT) per year (per manufacturer or importer), with some exemptions.

After June 1, 2007, the old (“pre-REACH”) chemical registration laws will disappear, and REACH will replace it. New chemical substances introduced into the EU after June 1, 2008, and in volumes above 1 MT per year, will require immediate registration, including the full REACH data set and risk assessment. Requirements for existing substances, also known as phase-in substances, are discussed below.

Phased Approach

REACH takes a phased approach to the registration requirements for substances currently on the market. As the term “phase-in substance” implies, the registration requirements for these substances will be phased in over a period of 11 years. A “phase-in substance” means a substance listed in EINECS or manufactured in one of the current EU Member States at least once within the period of 15 years before the entry into force of REACH, but not placed on the market.

Pre-Registration

The pre-registration process is a key element of REACH. Pre-registration is necessary for anyone wishing to achieve phase-in status for their substances and to receive up to 11 years to gather the required registration information—depending on the tonnage and classification of the substance. If you are unsure about the need to register, pre-register!

The designated pre-registration period is from June 1, 2008 through December 1, 2008. To ensure phase-in status of your substances, it is recommended that you identify substances needing to be registered and assemble the information required for pre-registration. If you neglect to pre-register, you lose the advantage of the 11-year phase-in process, and will have to register without delay. Pre-registration will also help establish the Substance Information Exchange Forums (SIEFs) initiated for the purpose of sharing hazard data.

Registration

Registration of any substance requires much more information than pre-registration. Registration timelines have been prioritized by volume and hazard. For example, substances in commerce above 1,000 MT per year and high-risk substances—such as carcinogens and reproductive toxins—must have complete hazards data and risk assessments completed by the year 2010. However, lower volume and less hazardous substances have a timeline that extends to 2018.

Registration requires submission of a technical dossier of information about the chemical that includes a complete set of hazard data. Compilation of hazard data is a joint effort by registrants of the same substance, through participation in a SIEF.

For substances manufactured or imported in quantities over 10 tons per year, the registration package also requires the submission of a Chemical Safety Report (CSR), which details a chemical safety assessment. This is a risk assessment where the registrant takes into account the risk management measures necessary for safe use. In addition, if the substances are considered “dangerous,” then an “exposure scenario” is required for each identified use.

Exposure scenarios describe how to safely use and control chemicals during their life cycle. The exposure scenarios will be integrated into safety data sheets (SDS) for communication with distributors and downstream users.

In some circumstances, a substance in an article (i.e., a manufactured good) is subject to the REACH registration requirements. Specifically, this includes substances that are released from the article during normal and reasonably foreseeable conditions of use. Also, notification to the Agency may be required under certain conditions if the manufactured articles contain substances of very high concern (SVHC).

Evaluation

Evaluation is a process by which registration dossiers can be examined. It may result in a request for more information on a substance from a registrant. There are two types of evaluations, each with a different goal. Dossier evaluations take place as part of the registration process and are only checked for completeness by the agency. Member State substance evaluations take place for substances designated as a possible risk to human health or the environment. Substances selected for evaluation probably will be prioritized by volume and degree of hazard.

Authorization

“High concern” substances will require authorization—regardless of the quantity on the market. Authorization will require a review of specific end uses for high concern substances, prior to use. Suppliers of these substances must demonstrate their use of appropriate risk management measures, the socio-economic benefit from substance use, and a substitution plan for the substance. Each authorized substance will be reviewed after a certain time limit that is specific to each substance. Downstream users must report use of authorized substances to ECHA.

While the final listing of substances of high concern is still being compiled, it will include:

Substances classified as very persistent and very bioaccumulative (vPvB).

Endocrine disruptors.

Other substances causing probable serious and irreversible effects to humans or the environment.

Restrictions of substances may be proposed by member state authorities.

Understanding Supply Chain Role

Each link in the supply chain must understand both its role and subsequent responsibility:

Material suppliers need to know what substances they are manufacturing and/or importing into the EU and expected volumes. They need to identify substances that will require registration and chemical safety reports (including exposure scenarios, risk management measures) and authorization information (where needed).

Equipment suppliers (e.g., semiconductor equipment manufacturers) need to determine if chemicals are present in their equipment (i.e., “articles”) and if the chemical is designed for release under normal use conditions. Exposure information on equipment use and equipment maintenance activities may be requested by downstream users. Clearly equipment suppliers should also consider any process recommendations provided to end users, plus any subsequent REACH obligations, which may get passed on to end users by the use of those processes. Also, it is recommended that equipment suppliers become aware of the REACH status of the chemicals processed in their equipment.

Downstream users (e.g., chip makers) should be prepared to provide exposure scenario information and remarks on risk management measures. In addition, they need to communicate all new information observed on product/substance hazards to their upstream suppliers.

As industry continues to define the REACH requirements and determines how to meet those requirements, areas of concern are also being identified. Concerns include: potential supply chain interruptions, the availability of adequate information on imported formulations, intellectual property concerns, including management of confidential business information.

REACH is a reality and one that industry will be managing for many years. The investment made today—to understand the requirements that apply to all roles in the supply chain and make preparations to meet requirements—can help assure a smooth transition to this expansive EU regulation and minimize REACH efforts in the future.

For additional details on REACH requirements, see the following websites: